Second Impurity Identified in Recalled Valsartan Products

N-Nitrosodiethylamine is a known animal and suspected human carcinogen

An additional impurity, N-Nitrosodiethylamine (NDEA), has been identified in some of the recalled valsartan products (160mg [lot BV47D001] and 320mg [lots BV48D001 and BV48D002]) from Torrent Pharmaceuticals.

NDEA is a known animal and suspected human carcinogen. The FDA began testing valsartan for NDEA after learning that Zhejiang Huahai Pharmaceuticals (ZHP) found NDEA in its active pharmaceutical ingredient (API); Torrent Pharmaceuticals uses the valsartan API from Zhejiang Huahai.

“As we expand our investigational efforts, we’ll continue to make sure the public has the most up-to-date information,” said FDA Commissioner, Scott Gottlieb, MD. “We’ll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients’ health around the globe.”

In July, several valsartan medications were recalled due to the detection of N-nitrosodimethylamine, an impurity classified as a probable human carcinogen. The FDA will continue testing all products containing valsartan for these impurities; the Agency is also analyzing the potential risks these impurities pose to patients.

As valsartan is used to treat various cardiovascular conditions including heart failure and hypertension, patients should continue to take their medications until they have a replacement product. Not all valsartan-containing medications contain these impurities.